White Oils and Soft Paraffins

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1 FUCHS Pharmaceutical Products Innovative solutions need experienced advice Every product change should be preceded by expert consultation on the application in question. Our Special Products Team will be glad to advise on the right product for each application as well as the support services we can offer. Contact: White Oils and Soft Paraffins FUCHS LUBRICANTS (UK) PLC New Century Street, Hanley, Stoke-on-Trent, ST1 5HU Phone: +44 (0) Fax: +44 (0)

2 THE FUCHS GROUP FUCHS is the world s largest independent lubricant manufacturer. The Group comprises 55 operating companies with 34 production plants worldwide. In addition to products developed for industry in the UK, we have access to over 2,500 industrial FUCHS products from within the Group. Customers have available FUCHS technical expertise and experience on a global scale, providing access to international fluid technology. UK GROUP PROFILE The headquarters of the UK subsidiary of the FUCHS Group is located in Stoke-on-Trent. Our modern, highly automated production plant ensures we can offer exceptional levels of service and delivery. FUCHS UK has over 100 years experience of supplying lubricants within the UK. We have demonstrated excellent performance in all aspects of lubricant supply including lubricant quality, timely supply and health and safety compliance. Our UK manufacturing site is audited to the highest levels and we have been awarded a wide range of quality standards including BS OHSAS 18001, AS9100 REV C, and BS EN ISO We hold the MHRA Medicines Manufacturing License. FUCHS has over 40 years experience in the production of White Soft Paraffins which are used by many pharmaceutical and cosmetics companies worldwide. We are in the unique position of being the only European manufacturer of White Soft Paraffins with a medicines manufacturing licence. Our specialist manufacturing plant is audited by the UK s Department of Health via the MHRA, in order for us to maintain the Medicines and European Good Manufacturing Practices Licence. Our quality controls and systems enable us to manufacture some of the world s most consistent and pure products. MANUFACTURING EXCELLENCE Our production plant is the most modern and efficient lubricant blending facility in the UK, with state of the art process control and quality management systems. The site has a production capacity of 20,000 tonnes per annum for pharmaceutical products, 5,000 pallet storage locations and bulk fluid handling capabilities. The FUCHS engineering team undertakes a continuous improvement programme to maximise and improve production efficiency even further. EXPERIENCE YOU CAN TRUST Lubricant suppliers are common, but lubricant suppliers with the expertise, service support and experience of FUCHS in the pharmaceutical industry are limited. In choosing a partner, you need confidence in their ability to understand the requirements of the pharmaceutical industry, and have the technology, intellect and support services to deliver. FUCHS is that partner. We have over 40 years experience of manufacturing and supplying White Soft Paraffins, specialist products and technical services to the pharmaceutical and cosmetics industries. 2 3

3 WHITE OILS PRODUCT INFORMATION FUCHS White Oils are highly refined mineral hydrocarbons, consisting of saturated aliphatic hydrocarbons. FUCHS White Oils maintain a safe, highly hydrophobic, colourless and tasteless character next to the skin which makes them ideal for pharmaceutical and cosmetic uses. Highly resistant to bacterial spoilage and naturally unable to block skin pores, FUCHS White oils set the standard in purity and safety. Uses FUCHS White Oils are the ideal choice for both cosmetic and pharmaceutical bases. They are classed as inert products in cosmetic and pharmaceutical applications which gives their natural lubricating and soothing nature full reign in uses ranging from baby oils and lotions to cleansing tissue and eye drops. FUCHS White Oils are also used extensively in food applications. Whether they are used for lubricating food machinery or dividing dough bakeries our products show the highest performance and cleanliness attributes associated with these important industries. Our Products Can be supplied in bulk and barrels to the highest European Good Manufacturing Practice Standards in our custom built, computer controlled facility. A wide viscosity range can be catered for providing blends suitable for all our customers needs. FUCHS White Oils are produced to meet the European Pharmacopoeia standards for Light and Liquid Paraffins and also meet the requirements for the USP / NF Mineral and Light Mineral Oil USP. In addition to this FUCHS White Oils meet FDA21 CFR and (a) for direct food contact. FUCHS Lubricants (UK) Plc maintains a Medicines Licence for the blending, storage and filling of all medicinal and cosmetic grade white oil which is confirmed by audit by the UK s Department of Health via the MHRA. WHITE OILS RELATIVE DENSITY AT 20 O C DYNAMIC VISCOSITY AT 20 O C mpa.s (TYPICAL) KINEMATIC VISCOSITY AT 40 O C mm2/s VISCOSITY AT 37.8 O C SUS (TYPICAL) Test Method ASTM D445 ASTM D445/IP71 ASTM D445 SILK SIRIUS M SILK SIRIUS M55 SILK SIRIUS M70 SILK SIRIUS M85 SILK SIRIUS M125 SILK SIRIUS M180 SILK SIRIUS M Test Method ASTM D1298/ IP160 ASTM D445/IP71 ASTM D445 TECHNICAL SIRIUS T

4 PRODUCT INFORMATION FUCHS Soft Paraffins (Petrolatum) are a semi-solid purified mixture of hydrocarbons containing waxes and oil. FUCHS Soft Paraffins are odourless and range in colour from pure white to yellow depending on the desired effect. The melting range and consistency dictate overall performance which is designed to retain structure but can still be easily spread on the skin. FUCHS Soft Paraffins are occlusive by nature and are extremely hydrating to the skin. Uses FUCHS Soft Paraffins are used extensively in the cosmetic, personal care and pharmaceutical industries. They are used as base components in creams, lotions and ointments meeting the requirements of the European Pharmacopoeia, United States Pharmacopoeia and Japanese Pharmacopeias making them ideal for use in medicinal products. A fact confirmed by the UK Department of Health who audit the FUCHS Soft Paraffins manufacturing facility in order to maintain Medicines and European Good Manufacturing Practices Licenses. Our Products FUCHS holds Europe s only Medicines Licence for the manufacture and distribution of Soft Paraffins and, as such, has a leading position within the market. All our grades meet the European Pharmacopoeia Monograph as a minimum, and our quality régime enables us to manufacture some of the world's most consistent and pure products. WHITE DROP POINT CONSISTENCY (CONE PENETRATION NO. AT 25 O C - mmx10-1 ) APPEARANCE COLOUR (2" CELL) Test Method IP 371 IP 179 IP 17 WSP SILK 783L Y max WSP SILK 783LP /USP WSP SILK 944 WSP SILK 895 YELLOW YSP SILK 775 YSP SILK 775P /USP WSP SILK 902H TECHNICAL YELLOW Y max Y max Y max Y + 2R max Y + 2R max Y + 2R max DROP POINT UNWORKED PENETRATION NO. AT 25 O C - mmx10-1 ) APPEARANCE Test Method IP 371 IP 179 Visual TECHNICAL YSP YELLOW/BROWN 6 7

5 WHITE OILS PRODUCT CODE PRODUCT PACK SIZE SILK SIRIUS M40 170KG SILK SIRIUS M55 17KG SILK SIRIUS M70 174KG PACKAGING SILK SIRIUS M85 SILK SIRIUS M125 SILK SIRIUS M350 /USP TECHNICAL SIRIUS T85 850KG 174KG 17KG 850KG IBC 174KG 862KG IBC 177KG 17KG 850KG IBC 174KG 17KG QUALITY & SUPPORT QUALITY STANDARDS The FUCHS Manufacturing Plant strictly adopts GMP in accordance with The Orange Guide (Rules & Guidance for Pharmaceutical Manufacturers and Distributors) for Medicinal Products for Human Use in compliance with EC Directive 2003/94/EC. We have a strict quality control procedure for the receipt of raw materials and packaging: all raw materials are tested before unloading into our bulk tanks and all packaging is from approved sources and is statistically sampled. Full Pharmacopeia Monograph testing is carried out on all pack sizes. RESEARCH & DEVELOPMENT The FUCHS Group has a strong focus on R&D and technical support, having more than 400 chemists, engineers and specialists in over 40 laboratories worldwide. The UK labs are extremely well equipped and audited to the highest levels. We have a wealth of experience at FUCHS and are committed to training up the chemists of the future. Our team comprises of highly trained individuals including employees with qualifications such as Chartered Chemist CChemMRSC, BSc Hons Chemistry, PHD Synthesis of Vinyl Phosphate Monomers. PRODUCT CODE PRODUCT PACK SIZE WSP SILK 783L 48KG 12.5KG WSP SILK 783LP /USP/JP 172KG WSP SILK WSP SILK 895 WSP SILK 895L YSP SILK 775 /USP YSP SILK 775 /USP 18KG 180KG 18KG 48KG 12.5KG 48KG 12.5KG YSP SILK 775P 192KG WSP SILK 902H 192KG TECHNICAL YSP KG SPECIALIST PRODUCTION We have dedicated manufacturing vessels, filling equipment and pumping systems for our pharmaceutical products. Our filling room has positive air pressure and air filtered to EU7 standards. Our unique manufacturing technology utilises vacuum steam distillation resulting in smooth product of superior quality - providing long term stability for pharmaceutical and cosmetic end products. Operations and procedures for the production of White Soft Paraffins are under the control of Registered Qualified Persons. Products are released in accordance with Article 51 of EC Directive 2001/83/EC. STORAGE & DISTRIBUTION All of our Soft and Liquid Paraffin finished products are stored in a GMP (Good Manufacturing Practices) certified warehouse which is clean, dry, and has active pest control measures. Bulk products are delivered in strictly controlled vehicles. Packaged products are protected from the elements during road trailer transportation. Logistical support is increased through active vehicle tracking and utilisation programmes, ensuring that the FUCHS delivery fleet is highly efficient. 8 9

6 FOR ALL WHITE OILS AND SOFT PARAFFIN ENQUIRIES John Holdcroft Trade & Export Manager Mobile: +44 (0) Office: +44 (0) Estelle Robinson Sales Executive Mobile: +44 (0) Office: +44 (0) Julia Wood Trade Specialist Office: +44 (0) Adrian Day Sales Executive Mobile: +44 (0) Office: +44 (0) Tracy Hargreaves Trade Specialist Office: +44 (0) General enquiries: +44 (0) Website: Information contained in this brochure was correct at the time this publication was printed. Please be aware that this information may change due to continual product development within this field. Always read the Safety Data Sheet before handling a product